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MapLight Therapeutics, Inc. · 2 days ago

Senior Manager, Medical Writing

Burlington, MA

Full-time

Hybrid

Senior Level

$168K/yr - $205K/yr

5+ years exp

MapLight Therapeutics is a clinical stage biotech company focusing on drug discovery for central nervous system disorders. The Senior Manager, Medical Writing will be responsible for authoring and managing high-quality medical and scientific documents to support product development and regulatory approval, collaborating closely with cross-functional teams to ensure compliance and timely deliverables.

BiopharmaBiotechnologyLife ScienceMedical

Responsibilities

Author and manage regulatory documents for global submissions in accordance with ICH and other international guidelines, internal standards, and project timelines

Lead and coordinate medical writing activities for assigned programs, including internal teams and external vendors, ensuring timely and accurate submissions to regulatory authorities

Provide strategic input on medical writing deliverables, timelines, and processes during cross-functional meetings

Drive process improvements and serve as a subject matter expert on document types, workflows, and technologies

Partner with the Head of Medical Writing to evaluate and implement innovative approaches to document development, review, and quality control

Partner with the Head of Medical Writing to develop and maintain SOPs, templates, and best practices to ensure consistency and efficiency in document preparation

Oversee contract writers as needed, including defining scopes of work and monitoring deliverables and budgets

Apply therapeutic area and product knowledge to ensure scientific accuracy and clarity in all documents

Collaborate with internal stakeholders to establish style standards and quality control measures for high-quality outputs

Qualification

Medical writingRegulatory requirements knowledgeMedical writing tools proficiencyProject managementAnalytical skillsAttention to detailInterpersonal skillsCollaboration

Required

Master's degree with at least 5 years of medical writing experience in pharma/biotech required

In-depth knowledge of regulatory requirements and guidelines (ICH, GCP, FDA, EMA) and familiarity with AMA style

Exceptional writing, editing, and verbal communication skills

Strong project management skills with the ability to prioritize and manage multiple projects

Proficiency with medical writing tools and software

Meticulous attention to detail and commitment to quality

Solid understanding of the drug development process and strong business acumen

Collaborative team player with strong interpersonal skills and ability to build effective relationships across functions and with external partners

Preferred

Advanced degree (PhD, PharmD) in a scientific discipline preferred

Experience managing vendors and contractors is a plus

Strategic thinker with analytical skills and ability to thrive in a fast-paced environment

Benefits

Annual bonus opportunity

Medical

Dental

Vision

Life and AD&D

Short term and long term disability

401(K) plan with match

Stock options

Flexible non-accrual paid time off

Parental leave

Company

MapLight Therapeutics, Inc.

Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS).

Founded in 2018

Palo Alto, California, USA

51-200 employees